Study of the Aliviado DSD Caregiving Mastery Program

Development and Piloting of a Family-Centered, mHealth-Enhanced Intervention to Promote Caregiving Mastery in Detection, Prevention, and Management of Delirium Superimposed on Dementia

Delirium superimposed on dementia (DSD) is an acute and serious condition that is common in persons living with dementia (PLWD). Involvement of family caregivers may aid prevention, early detection, and management of DSD. The purpose of the proposed study is two-fold. First, the investigators will develop a family-centered, mHealth-enhanced DSD caregiving mastery program ("Aliviado DSD Caregiving Mastery Program") through a 5-week co-design workshop with 8 family caregivers (Aim 1). The investigators will adapt/refine the existing clinician-centered DSD contents and an mHealth app from the evidence-based "Aliviado Dementia Care" program for use by family caregivers to support their day-to-day implementation of DSD detection, prevention, and management tasks in the community. Second, the investigators will pilot test the full Aliviado DSD Caregiving Mastery Program with family caregivers of PLWD at high risk for delirium, assessing feasibility, acceptability, app usability, and preliminary program impact (Aim 2).

Study Overview

• Status: Completed
• Conditions: Delirium Superimposed on Dementia
• Intervention / Treatment: Behavioral: Aliviado DSD Caregiving Mastery Program

• Study Type: Interventional
• Enrollment (Actual): 33
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10010
      • NYU Langone Health
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15260
      • University of Pittsburgh

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

To be eligible as a "dementia caregiver" in the co-design workshop, an individual must:

• be at least 18 years old,
• be English-speaking,
• provide at least 8 hours of unpaid care weekly or live with a community-dwelling PLWD,
• self-identify as unfamiliar with DSD,
• have the capacity to consent, and
• have Internet access

To be eligible as a "DSD caregiver" in the co-design workshop, an individual must:

• be at least 18 years old,
• be English-speaking,
• be a current or past dementia caregiver with experience caring for a relative or friend during his/her DSD episode within the past 12 months,
• have the capacity to consent, and
• have Internet access.

To be eligible to participate in the feasibility trial, an individual must meet all of the following criteria:

• Being 18 years old or older,
• English-speaking,
• Providing at least 8 hours of unpaid care per week to, or living with, a community dwelling PLWD whose Delirium Risk Assessment Score >=5,
• Having the capacity to give informed consent, and
• Having a smartphone with Internet access.

Exclusion Criteria:

• Individuals who are blind or deaf will be excluded.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Family Caregivers of PLWD at High Risk for Delirium; Participants will complete the Aliviado DSD Caregiving Mastery Program. This involves a caregiver education/training period from Week 0 to Week 2, and an implementation period from Week 3 to Week 6.	Behavioral: Aliviado DSD Caregiving Mastery Program; Family caregiver intervention consisting of mHealth-app based educational videos and articles; caregiver-administered assessment tools and care plans; and motivational push notification reminders and encouragements.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Who Complete the Study	Measure of feasibility. Feasibility indicated by retention rate of 85%.	Week 6
Program Satisfaction Questionnaire Score: Satisfaction	Measure of acceptability. Acceptability was indicated by at least 80% of caregivers reporting high satisfaction. The questionnaire comprised 16 items, including 12 Likert-type questions assessing program satisfaction, one Yes/No question assessing caregivers' intention to make changes in how they provide care for PLWD based on what they learned from the program, and three open-ended questions for additional feedback. Each Likert-type item was rated on a 4-point scale (1 = strongly disagree; 2 = disagree; 3 = agree; 4 = strongly agree). The total satisfaction score was calculated as the sum of the 12 Likert-type items, yielding a possible range of 12-48, with higher scores indicating greater satisfaction (high satisfaction defined as a score > 36). This outcome is measured as the number of participants with a high satisfaction score.	Week 6
Program Satisfaction Questionnaire Score: Intention to Change	Measure of acceptability. Acceptability was indicated by at least 80% of caregivers responding "Yes" to the Yes/No question on the Program Satisfaction Questionnaire: "Will you make any changes in how you care for your relative or friend with dementia based on what you learned in this program?" This outcome is measured as the number of participants who answer "Yes" to the intention-to-change question.	Week 6
Number of Participants Who Complete All Training Videos by Week 2	Measure of acceptability.	Up to Week 2
Number of Participants Who Complete Weekly Delirium Screening at Least Twice by Week 6	Measure of acceptability.	Up to Week 6
Modified IBM Computer Usability Satisfaction Questionnaire Score	Modified by the Aliviado team to assess the usability of mobile apps, it consists of (1) 22 Likert-type questions rated on a scale from 1 to 5 (1="Strongly Disagree"; 2 ="Disagree"; 3="Neither agree or disagree"; 4="Agree" 5="Strongly Agree") assessing app usability, content, and interface; (2) one 4-point item on readiness to launch; (3) three Yes/No questions assessing frequency of app use and internet connectivity; and (4) three open-ended questions to provide additional feedback. The total usability satisfaction score is calculated by averaging responses to the twenty-two 5-point Likert-type items related to app usability, content, and interface. A score of 4 or higher indicates high user satisfaction and good usability.	Up to Week 6

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Caregiver Delirium Knowledge Questionnaire Score at Week 2	19-item assessment of caregivers' delirium knowledge. Item response options include "yes," "no," and "I don't know." Correct responses receive a score of 1, incorrect responses receive a score of 0. The total score ranges from 0-19; higher scores indicate greater delirium knowledge.	Baseline, Week 2
Change From Baseline in Caregiver Delirium Knowledge Questionnaire Score at Week 6	19-item assessment of caregivers' delirium knowledge. Item response options include "yes," "no," and "I don't know." Correct responses receive a score of 1, incorrect responses receive a score of 0. The total score ranges from 0-19; higher scores indicate greater delirium knowledge.	Baseline, Week 6
Change From Baseline in Modified Caregiver Strain Index Score at Week 6	13-item assessment of strain related to care provision. Items are scored on a Likert scale from 0 (no) to 2 (Yes, on a regular basis). The total score is the sum of responses and ranges from 0 to 26; higher scores indicate greater strain.	Baseline, Week 6
Change From Baseline in Center for Epidemiological Studies Depression Scale (CES-D) Score at Week 6	20-item assessment of symptoms of depression over the past 7 days. The total score ranges from 0 to 60, with higher scores indicating the presence of more symptomatology.	Baseline, Week 6
Change From Baseline in Short Form Zarit Burden Interview Score at Week 6	12-item assessment of caregiver burden. Items are scored on a Likert scale from 0 (never) to 4 (nearly always). The total score is the sum of responses and ranges from 0 to 48. A score of 0-10 indicates no to mild burden; 10-20 indicates mild to moderate burden; and greater than 20 indicates high burden.	Baseline, Week 6
Change From Baseline in DSD Caregiving Mastery Assessment Score (Competence) at Week 2	4-item DSD Competence Scale modified from Pearline's Competence Scale. Each item is rated on a scale from 1-4. The total score is the sum of responses and ranges from 4 to 16. Higher scores indicate greater levels of mastery.	Baseline, Week 2
Change From Baseline in DSD Caregiving Mastery Assessment Score (Competence) at Week 6	4-item DSD Competence Scale modified from Pearline's Competence Scale. Each item is rated on a scale from 1-4. The total score is the sum of responses and ranges from 4 to 16. Higher scores indicate greater levels of mastery.	Baseline, Week 6
Change From Baseline in DSD Caregiving Mastery Assessment Score (Self-Efficacy) at Week 2	25-item DSD self-efficacy scale developed by the Aliviado team to assess confidence of DSD prevention, detection, and management tasks. Each item is rated on a scale from 0-100. The total score is the average of sum of non-missing responses and ranges from 0 to 100. Higher scores indicate greater levels of mastery.	Baseline, Week 2
Change From Baseline in DSD Caregiving Mastery Assessment Score (Self-Efficacy) at Week 6	25-item DSD self-efficacy scale developed by the Aliviado team to assess confidence of DSD prevention, detection, and management tasks. Each item is rated on a scale from 0-100. The total score is the average of sum of non-missing responses and ranges from 0 to 100. Higher scores indicate greater levels of mastery.	Baseline, Week 6

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Collaborators: National Institute on Aging (NIA)
• Investigators: Principal Investigator: Shih-Yin Lin, NYU Rory Meyers College of Nursing

Study record dates

Study Major Dates

• Study Start (Actual): December 20, 2023
• Primary Completion (Actual): February 11, 2025
• Study Completion (Actual): February 11, 2025

Study Registration Dates

• First Submitted: November 18, 2022
• First Submitted That Met QC Criteria: November 18, 2022
• First Posted (Actual): November 29, 2022

Study Record Updates

• Last Update Posted (Actual): February 10, 2026
• Last Update Submitted That Met QC Criteria: January 22, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Delirium; Dementia
• Other Study ID Numbers: 22-01093

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: [SL199@nyu.edu]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
• IPD Sharing Time Frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
• IPD Sharing Access Criteria: The investigator who proposed to use the data will be granted access to the data upon reasonable request. Requests should be directed toSL199@nyu.edu. To gain access, data requestors will need to sign a data access agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No